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news.Nycomed, a pharmaceutical company focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management, has filed a marketing authorization application (MAA) for Teduglutide (Revestive) as a treatment for short bowel syndrome (SBS) with the European Medicines Agency (EMA).
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Teduglutide is a novel, recombinant analogue of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining.
Nycomed said the MAA for Teduglutide was filed on the basis of the positive results from a randomized, placebo-controlled study in SBS patients conducted in Europe, Canada and the US.
The results of the study suggested that Teduglutide 0.05mg/kg bodyweight reduces the need for parenteral support by at least 20% (46% of teduglutide-treated patients responded versus 6% of placebo-treated patients).
University Hospital of Copenhagen Department of Medical Gastroenterology Palle Bekker Jeppesen said the clinical data suggest that Teduglutide helps to improve intestinal function in SBS patients, thereby reducing dependence on parenteral nutrition, giving them better fluid and energy absorption and potentially improving their quality of life.
"The addition of teduglutide to the limited treatment armamentarium may increase the awareness of this debilitating condition and its submission brings us closer to an important new therapeutic option for our patients," Jeppesen said.